Beaumont Bio-Med Recalls Sinus Response Homeopathic Formula Due to CGMP Deviations
Beaumont Bio-Med, Inc. is recalling 90 bottles of Sinus Response Homeopathic Formula due to manufacturing deviations that could result in microbial contamination.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant risks such as microbial contamination are assigned a severity score of 4 (Severe).
Plain-English summary
Beaumont Bio-Med, Inc. is recalling 90 bottles of Sinus Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle. The product is identified by Lot 100316A and has an expiration date of 10/2019. The NDC number is 58066-7013-7.
The recall was initiated because the product was manufactured by a contract manufacturer under conditions that deviated from Current Good Manufacturing Practices (CGMP). These deviations could result in possible microbial contamination. The agency has classified this recall as Class II.
The product was distributed nationwide in the USA. Consumers who possess this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Sinus Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7013-7
- Manufacturer
- Beaumont Bio-med, Inc.
- Category
- Drug — Homeopathic
- Hazard
- Affected units
- 90
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 100316A
- Exp 10/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Beaumont Bio-med, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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